From the very beginning of our project, doctors, researchers and engineers have worked together to provide each patient with an effective and individualised treatment. The work done since then tends to make the most advanced medical techniques accessible to all.
We want to allow the greatest number of patients suffering from chronic neurological or psychiatric pathologies to have access to the best possible care through neurostimulation.
To this end, and with a constant concern for patient and user safety, Syneika has set the following objectives :
✔ offer ever more effective, safe and universally usable care solutions using non-invasive neurostimulation of the cortex.
✔ support users in the daily development of their care activity.
✔ share with doctors and their teams the best therapeutic practices and the best technological tools emerging from research.
✔ make caregivers and patients aware of neurostimulation and give them access to it.
Syneika has implemented a Quality Management System enabling it to pursue these objectives. That is to say that all is done to satisfy the needs of our customers in compliance with regulations and continuously improve our performance.
This management system is compliant with the ISO 13485:2016 standard and with the 93/42/EEC directive relating to the marketing of medical devices. Meanwhile, we are actively preparing for the implementation of the requirements of the new medical device regulation (Regulation 2017/745) and already apply the “Transitional Provisions” of Article 120 of this Regulation.
This Quality Management System applies to all Syneika activities and to all medical devices designed, developed, manufactured or marketed by Syneika.
Thus, PowerMAG magnetic stimulators and Syneika One neuronavigators are CE marked medical devices. Therefore, they comply with the high safety requirements of the EN 60601-1 standard as well as with all the requirements induced by the medical devices regulation.